US10271960B2 - Decoupled spacer and plate and method of installing the same - Google Patents

Abstract

Intervertebral spacer assemblies, systems, and methods thereof. A method of insertion includes inserting an intervertebral spacer and plate together using an insertion tool and, upon removal of the insertion tool, the intervertebral spacer and plate are no longer considered connected/coupled and act as separate components.

Description

REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. application Ser. No. 15/661,027, which is a continuation-in-part application of U.S. application Ser. No. 15/479,438, filed Apr. 5, 2017, which are hereby incorporated by reference in their entireties for all purposes.

BACKGROUNDField of the Invention

The present invention relates to bone fixation, and more specifically, to a method of installing an intervertebral spacer and plate.

Description of the Related Art

Various types of spacers can be used in spinal fusion procedures. A standalone spacer is one in which a spacer is attached to a plate. The plate is configured to receive one or more screws that secure the standalone spacer to one or more adjacent vertebrae. The combined spacer/plate structure is typically rigid, thereby reducing the flexibility of the patient at the implant site.

There exists a need for intervertebral spacer and plate assemblies that are inserted as a unit with an insertion tool, but are decoupled from each other when the insertion tool is removed. Further, methods of inserting the assemblies are also needed.

SUMMARY

To meet this and other needs, implants, systems and methods are provided to permit the insertion of a plate and spacer together or separately. If the plate and spacer are used together, a holder or group of holding instruments can be used to hold both the plate and spacer together during the insertion process. For example, the attachment of the plate, spacer and holder may be provided with a threaded rod without violating the graft space within the spacer. Additionally, embodiments may include a threaded rod and holder whose material and geometry lend to the rod curving within the holder, permitting the angular attachment of these components. Other embodiments of the plate, spacer, and instruments are described herein.

According to one embodiment, a method of installing an intervertebral spacer and plate assembly may include coupling an intervertebral spacer and plate to an insertion tool; delivering the coupled spacer and plate to a surgical site via the insertion tool, wherein the spacer and/or plate are received in an intervertebral disc space; inserting one or more bone screws into the plate to secure the plate to one or more adjacent vertebrae; and removing the insertion tool, such that the spacer is decoupled from the plate at the surgical site.

BRIEF DESCRIPTION OF THE DRAWINGS

Other aspects, features, and advantages of the present invention will become more fully apparent from the following detailed description, the appended claims, and the accompanying drawings in which like reference numerals identify similar or identical elements.

FIG. 1 is a perspective view of a spacer and plate assembly according to a first exemplary embodiment;

FIG. 2 is a perspective view of the spacer shown inFIG. 1;

FIGS. 3-6 show a top plan view, posterior elevational view, left lateral side elevational view, and right lateral side elevational view, respectively of the spacer shown inFIG. 2;

FIG. 7 is a perspective view of the plate shown inFIG. 1;

FIGS. 8-11 show a posterior elevational view, top plan view, left lateral side elevational view, and right lateral side elevational view, respectively, of the plate shown inFIG. 7;

FIGS. 12-14 show a top plan view, posterior elevational view, and right lateral side elevational view, respectively, of the assembly shown inFIG. 1;

FIG. 15 is a left lateral side elevational view of the spacer ofFIG. 1;

FIG. 16 is a perspective view of the assembly components shown inFIG. 1 and an insertion tool for inserting the assembly;

FIG. 17 is a perspective view showing the plate ofFIG. 7 having been inserted onto the insertion tool;

FIG. 18 is a perspective view showing the spacer and plate assembly ofFIG. 1 having been inserted onto the insertion tool;

FIG. 19 is a top plan view, in section, of the plate and spacer of the assembly shown inFIG. 1 having been inserted onto the insertion tool;

FIG. 20 is a top plan view of a spacer and plate assembly according to a second exemplary embodiment;

FIGS. 21-24 are a posterior elevational view, left lateral side elevational view, exploded posterior perspective view, and exploded anterior perspective view, respectively, of the assembly shown inFIG. 20;

FIG. 25 is a top plan view, in section, of the plate ofFIG. 20 and an insertion tool for inserting the plate;

FIG. 26 is a perspective view of the plate and insertion tool ofFIG. 25;

FIG. 27 is a top plan view, in section, of the assembly ofFIG. 20 and the insertion tool for inserting the assembly;

FIG. 28 is a perspective view of the assembly and insertion tool ofFIG. 27;

FIG. 29 is a top plan view, in section, of a spacer block and the spacer and insertion tool ofFIG. 27;

FIG. 30 is a perspective view of the spacer block, spacer, and insertion tool ofFIG. 29;

FIG. 31 is a top plan view of a spacer and plate assembly according to a third exemplary embodiment;

FIGS. 32-35 are a posterior elevational view, left lateral side elevational view, exploded anterior perspective view, and exploded posterior perspective view, respectively, of the assembly shown inFIG. 31;

FIG. 36 is a top plan view, in section, of the plate ofFIG. 31 and an insertion tool for inserting the assembly ofFIG. 31;

FIG. 37 is a perspective view of the plate and insertion tool ofFIG. 36;

FIG. 38 is a top plan view, in section, of the assembly ofFIG. 31 and the insertion tool for inserting the assembly;

FIG. 39 is a perspective view of the assembly and insertion tool ofFIG. 38;

FIG. 40 is a top plan view, in section, of a spacer block and the spacer and insertion tool ofFIG. 38;

FIG. 41 is a perspective view of the spacer block, spacer, and insertion tool ofFIG. 40;

FIG. 41A is an anterior perspective view of an alternative plate for use with the spacer shown inFIG. 20;

FIGS. 41B-41D are a left perspective view, left side elevational view, anterior side elevational view, respectively of the plate shown inFIG. 41A;

FIG. 42 is a top plan view of a spacer and plate assembly according to a fourth exemplary embodiment;

FIGS. 43-46 are a posterior elevational view, left lateral side elevational view, exploded anterior perspective view, and exploded posterior perspective view of the assembly shown inFIG. 42;

FIG. 47 is a top plan view, in section, of the plate ofFIG. 42 and an insertion tool for inserting the assembly ofFIG. 42;

FIG. 48 is a perspective view of the plate and insertion tool ofFIG. 47;

FIG. 49 is a top plan view, in section, of the assembly ofFIG. 42 and the insertion tool for inserting the assembly;

FIG. 50 is a perspective view of the assembly and insertion tool ofFIG. 49;

FIG. 51 is a top plan view, in section, of a spacer block and the spacer and insertion tool ofFIG. 49;

FIG. 52 is a perspective view of the spacer block, spacer, and insertion tool ofFIG. 51;

FIG. 53 is a top plan view of a spacer and plate assembly according to a fifth exemplary embodiment;

FIGS. 54-57 are a posterior elevational view, left lateral side elevational view, exploded anterior perspective view, and exploded posterior perspective view, respectively, of the assembly shown inFIG. 53;

FIG. 58 is a top plan view, in section, of the assembly ofFIG. 53 attached to an insertion tool for inserting the assembly ofFIG. 53;

FIG. 59 is a perspective view of the assembly and insertion tool ofFIG. 58;

FIG. 60 is a top plan view, in section, of the plate ofFIG. 53 and the insertion tool for inserting the plate;

FIG. 61 is a perspective view of the plate and insertion tool ofFIG. 60;

FIG. 62 is a top plan view, in section, of a spacer block and the spacer and insertion tool ofFIG. 59;

FIG. 63 is a perspective view of the spacer block, spacer, and insertion tool ofFIG. 62;

FIG. 64 is a top plan view of a spacer and plate assembly according to a sixth exemplary embodiment;

FIGS. 65-67 are a left lateral side elevational view, posterior elevational view, and exploded anterior perspective view, respectively, of the assembly ofFIG. 64;

FIG. 68 is a perspective view of a spacer and plate assembly according to a seventh exemplary embodiment;

FIG. 69 is a perspective view of a spacer used with the assembly shown inFIG. 68;

FIG. 70 is a perspective view of a plate used with the assembly shown inFIG. 68;

FIGS. 71-74 are a top plan view, anterior elevational view, right side elevational view, and left side elevational view, respectively, of the spacer shown inFIG. 69;

FIGS. 75-78 are an anterior elevational view, top plan view, right side elevational view, and left side elevational view, respectively, of the plate shown inFIG. 70;

FIGS. 79-82 are a top plan view, anterior elevational view, right side elevational view, and left side elevational view, respectively, of the assembly shown inFIG. 68;

FIG. 83 is a perspective view of a spacer and plate assembly according to an eighth exemplary embodiment;

FIG. 84 is a perspective view of a spacer used with the assembly shown inFIG. 83;

FIG. 85 is a perspective view of a plate used with the assembly shown inFIG. 83;

FIGS. 86-89 are a top plan view, anterior elevational view, right side elevational view, and left side elevational view, respectively, of the spacer shown inFIG. 84;

FIGS. 90-93 is an anterior elevational view, a posterior elevational view, right side elevational view, and a top plan view of the plate shown inFIG. 85;

FIGS. 94-97 is a top plan view, anterior elevational view, right side elevational view, and left side elevational view of the assembly shown inFIG. 83;

FIG. 98 is a side elevational view, in section, of the assembly shown inFIG. 94, taken along lines98-98 ofFIG. 94;

FIG. 99 is a perspective view of a spacer and plate assembly according to a ninth exemplary embodiment;

FIG. 100 is a perspective view of a spacer used with the assembly shown inFIG. 99;

FIG. 101 is a perspective view of a plate used with the assembly shown inFIG. 99;

FIGS. 102-105 is a perspective view, top plan view, anterior elevational view, and posterior elevational view of the spacer shown inFIG. 100;

FIGS. 106-109 is top plan view, perspective view, anterior elevational view, and posterior elevational view of the plate shown inFIG. 101;

FIGS. 110-113 is a top plan view, anterior elevational view, right side elevational view, and left side elevational view of the assembly shown inFIG. 99;

FIG. 114 is an anterior elevational view of a spacer and plate assembly according to a tenth exemplary embodiment;

FIGS. 115-116 is a top plan view and right side elevational view of the assembly shown inFIG. 114;

FIG. 117 is a top plan view of a spacer and plate assembly according to an eleventh exemplary embodiment;

FIG. 118 is a top plan view of a spacer and plate assembly according to a twelfth exemplary embodiment;

FIG. 119 is a top plan view of a spacer and plate assembly according to a thirteenth exemplary embodiment;

FIG. 120 is a top plan view of a spacer and plate assembly according to a fourteenth exemplary embodiment;

FIG. 121 is a top plan view of a spacer and plate assembly according to a fifteenth exemplary embodiment;

FIG. 122 is a top plan view of a spacer and plate assembly according to a sixteenth exemplary embodiment;

FIG. 123 is posterior side elevation view of a spacer according to a seventeenth exemplary embodiment;

FIG. 124 is an anterior side elevation view of the spacer shown inFIG. 123;

FIG. 125 is a top plan view of the spacer shown inFIG. 123, with a plate and insertion device;

FIG. 126 is a top plan view of a spacer and plate assembly according to an eighteenth exemplary embodiment;

FIG. 127 is a posterior side elevation view of the assembly shown inFIG. 126;

FIG. 128 is a top plan view of a spacer and plate assembly according to a nineteenth exemplary embodiment;

FIG. 129 is a posterior side elevation view of the plate shown inFIG. 128;

FIG. 130 is a posterior side elevation view of the spacer ofFIG. 128;

FIG. 131 is a top perspective view of a spacer and plate assembly according to a nineteenth embodiment;

FIGS. 132-134 is a top view, side view, and posterior view of the assembly shown inFIG. 131;

FIG. 135 is a posterior view of the spacer shown inFIG. 131;

FIG. 136 is a top perspective view of the assembly shown inFIG. 131 attached to an insertion tool;

FIGS. 137-139 is a top view, side view, and bottom view of the assembly shown inFIG. 131 attached to an insertion tool;

FIGS. 140A-140C illustrate the insertion tool being attached to the spacer and plate assembly in accordance with some embodiments;

FIG. 141 is a top perspective view of a spacer and plate assembly according to a twentieth embodiment;

FIG. 142-145 is a top view, side view, bottom view, posterior view of the assembly shown inFIG. 141;

FIGS. 146A-146C illustrate the spacer and plate assembly with the gripping features of the plate in a neutral position in accordance with some embodiments;

FIGS. 147A-147C illustrate the spacer and plate assembly with the gripping features of the plate in a compressed position in accordance with some embodiments.

FIG. 148 is a top perspective view of a spacer and plate assembly according to a twenty-first embodiment;

FIG. 149 is a posterior view of the assembly shown inFIG. 148;

FIG. 150 is a sectional view of the asse3mbly shown inFIG. 149, taken along lines150-150 ofFIG. 149;

FIG. 151 is a posterior view of the spacer shown inFIG. 148;

FIG. 152 is a posterior view of the plate shown inFIG. 148;

FIG. 153 is a perspective view of the spacer and plate assembly ofFIG. 148, attached to a holder;

FIG. 154 is a top plan view of the spacer and plate assembly and the holder ofFIG. 153;

FIG. 155 is a side elevational view of the spacer and plate assembly and the holder ofFIG. 153;

FIG. 156 is a sectional view of the spacer and plate assembly and the holder ofFIG. 155, taken along lines156-156 ofFIG. 155;

FIG. 157 is a perspective view of the spacer and plate assembly and the holder ofFIG. 153, in a disassembled condition;

FIG. 158 is a perspective view of the spacer and plate assembly and the holder ofFIG. 157, with the shaft inserted into the holder;

FIG. 159 is a perspective view of the spacer and plate assembly and the holder ofFIG. 158, with the plate attached to the holder; and

FIG. 160 is a perspective view of the spacer and plate assembly and the holder ofFIG. 159, with the spacer attached to the holder.

DETAILED DESCRIPTION

In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.

In performing spinal fusion procedures, a spacer can be inserted into a disc space. In some embodiments, a standalone spacer can be attached to a plate. The plate can receive one or more bone anchors or screws to attach to the plate to one or more adjacent vertebrae. The plate and spacer are often rigidly connected and are not decoupled from one another.

The present application includes spacer and plate assemblies that can be coupled via an insertion instrument upon delivery to a surgical site. In some embodiments, a surgical site can be at or near a disc space, as one skilled in the art will appreciate. The insertion instrument advantageously provides a single tool for delivering both the spacer and plate if desired. Once the spacer and plate are implanted at the surgical site, the insertion instrument can be removed. With the insertion instrument removed, the spacer and plate are considered decoupled from one another. By providing a spacer and plate that are independent and decoupled from one another, a surgeon advantageously has the option to implant both a plate and a spacer, a spacer by itself, or a plate by itself if desired.

The present disclosure provides embodiments of intervertebral spacers and plates that can be used to space and fixedly secure two adjacent vertebrae. According to one embodiment, shown inFIGS. 1-19, an intervertebral spacer and plate assembly100 (“assembly100”) is provided. In an exemplary embodiment,assembly100 can be used for cervical repair, although those skilled in the art will recognize thatassembly100 can be sized for thoracic or lumbar repair as well.

Assembly100 is formed from two separate components, anintervertebral spacer102 and aplate104. In some embodiments,spacer102 andplate104 are not directly connected to each other, but are instead each separately coupled to aninsertion tool106, shown inFIGS. 16-19.

Referring toFIGS. 1-6,spacer102 includes abody108 having asuperior surface110 and an opposinginferior surface112. Each ofsuperior surface110 andinferior surface112 can have a plurality of protrusions orfixation elements114 extending outwardly therefrom. Whilefixation elements114 are shown as being generally pyramidal in shape, those skilled in the art will recognize thatfixation elements114 can be other shapes, such as ribbed, or other suitable shapes.Fixation elements114 are used to bite into a grip each of adjacent vertebrae (not shown) between which spacer102 is inserted.

As shown inFIG. 2,body102 can have a generally U-shape, with generally parallellateral sides116,118, connected to each other by an anterior portion120.Lateral side116 includes a convex arcuateposterior face117 whilelateral side118 includes a convex arcuateposterior face119. The space betweenlateral sides116,118 can optionally be filled with graft material. The advantage of a U-shaped body is that if a surgeon decides to use thespacer102 on its own, it can be easily backfilled through the opening of the “U”. Referring toFIGS. 2-4,superior surface110 alonglateral side118 includes acutout111 that slopes inferiorly in an anterior-to posterior direction. Similarly,inferior surface112 alonglateral side116 includes acutout113 that slopes superiorly in an anterior-to posterior direction.Cutouts111,113 allow for securing screws (not shown) to be inserted throughplate104, alongcutouts111,113, respectively, and into adjacent vertebrae (not shown) without engagingspacer102.

Lateral side116 includes a tubular protrusion122 extending in an anterior-posterior direction. Protrusion122 has an internally threadedpassage124 that is sized to accept a portion ofinsertion tool106 as will be explained in detail below.Passage124 can have a closedanterior end125.

Lateral side118 includes anopen slot126 that extends in an anterior-posterior direction. Ananterior end128 ofslot126 extends medially inward and is sized to accept a portion ofinsertion tool106 as will be explained in detail below.

Referring now toFIGS. 1 and 7-11,plate104 includes abody130 having asuperior surface132 and an opposinginferior surface134. In some embodiments, theplate104 is sized and configured to be received within a disc space, while in other embodiments, at least a portion of theplate104 is sized and configured to be received outside of a disc space. Each ofsuperior surface132 andinferior surface134 can have a plurality ofstabilizer elements136 extending outwardly therefrom. In some embodiments, thestabilizer elements136 can be for torsional stabilization. In an exemplary embodiment, onestabilizer element136 is located along a central anterior-to-posterior axis, and asecond stabilizer element136 is located proximate to a lateral side ofbody130. Whilestabilizer elements136 are shown as being generally ribbed in shape, those skilled in the art will recognize thatstabilizer elements136 can be other shapes, such as pyramidal, or other suitable shapes.Stabilizer elements136 are used to bite into a grip each of adjacent vertebrae (not shown) between which spacer102 is inserted.

As shown inFIG. 9,body130 can have a generally arcuate shape, with generally parallellateral sides138,140. Eachlateral side138,140 includes an anterior-to-posterior slot142,144, respectively.Slot142 includes asuperior surface146 and a generally parallelinferior surface148, whileslot144 includes asuperior surface150 and a generally parallelinferior surface152. As shown inFIG. 13, whenplate104 is aligned withspacer102 for insertion,slot142 is aligned with threadedpassage124 andslot144 is aligned withopen slot126.

Body130 includes a generally concave arcuateanterior face156 that mates with convex arcuate faces117,119 ofspacer102 whenplate104 is located againstspacer102, as shown inFIG. 12.Body130 also includes a generallyconvex posterior face158 that extends generally parallel toanterior face156.

Through-holes160,162 extend throughbody130 in a posterior-to-anterior direction. Through-holes160,162 are sized to allow a bone or securing screw (not shown) to be inserted therethrough to secureplate104 to each of a superior vertebra (not shown) and an inferior vertebra (not shown), between which spacer102 is being inserted. Through-hole160 extends in a superior-to-inferior direction so that its screw engages and secures to the inferior vertebra, while through-hole162 extends in an inferior-to-superior direction so that its screw engages and secures the superior vertebra.

A lockingscrew164 is disposed between through-holes160,162. Lockingscrew164 has ahead166 with diametrically opposedarcuate cutouts168,170 that are sized to allow the securing screws discussed above to be inserted into through-holes160,162. During insertion ofassembly100, lockingscrew164 is in a configuration relative to plate104 as shown inFIG. 8. After the securing screwssecure plate104 to the superior and inferior vertebra, lockingscrew164 is rotated, for example, about 90 degrees, so thathead166 extends over the securing screws, preventing the securing screws from inadvertently backing out.

FIGS. 1 and 12-15show assembly100. Whileplate104 abutsspacer102,plate104 is not rigidly connected tospacer102 in any way so thatspacer102 andplate104 remain separate, independent components. During insertion via an insertion tool, thespacer102 andplate104 can both be coupled to the insertion tool. After insertion to a surgical site, thespacer102 andplate104 are decoupled from one another.

Referring now toFIGS. 16-19,insertion tool106 is used to insertspacer102 andplate104.Insertion tool106 includes adistal end170 having a firstdistal finger172 and a seconddistal finger174 that extends generally parallel to firstdistal finger174. Agap176 betweenfingers172,174 forms a generallyU-shaped cavity176 that is sized to acceptplate104 therein, as shown inFIG. 17. This gap advantageously provides space for a surgeon to use a tool to insert one or more bone screws or anchors into the plate. Firstdistal finger172 includes arod178 having a threadedend180 that threads into threadedpassage124 in tubular protrusion122 onspacer102, as shown inFIG. 19.Rod178 has a proximal end (not shown) that can be rotated by the surgeon to threadingly secure threadedend180 into threadedpassage124.

Seconddistal finger174 includes aprong182 that extends generally toward firstdistal finger172.Prong182 is sized to fit intoanterior end128 ofslot126 onspacer102.

While asingle insertion tool106 is shown, those skilled in the art will recognize that multiple insertion tools can be used. For example, a first insertion tool having only firstdistal finger172 can be used in conjunction with a second insertion tool having only seconddistal finger174.

According to one embodiment, a method of installingassembly100, for example, at the site of two adjacent vertebrae (not shown), may include providingspacer102,plate104, andinsertion tool106 as a kit, as shown inFIG. 16. Referring toFIG. 17,plate104 is connected toinsertion tool106 such thatdistal end170 ofinsertion tool106 extends distally of plate104 (shown inFIG. 19).Plate104 is connected toinsertion tool106 by attachingplate104 to each offirst finger172 andsecond finger174.First finger172 is inserted intoslot142, whilesecond finger174 is inserted intosecond slot144.Plate104 is slid proximally onto each offirst finger172 andsecond finger174, withplate104 engaging each offirst finger172 andsecond finger174 with an interference fit.

Next, as shown inFIGS. 18 and 19,spacer102 is attached todistal end170 ofinsertion tool106 by attachingspacer102 to each offirst finger172 andsecond finger174. Sequentially or simultaneously,first finger172 is connected to spacer102 by threading threadedend180 that threads into threadedpassage124 in tubular protrusion122 onspacer102 and insertingprong182 onsecond finger174 intoslot126 onspacer102 and slidingspacer102 proximally untilprong182 engagesanterior end128 ofslot126, thereby frictionally engagingsecond finger174 withspacer102.

Afterassembly100 is attached toinsertion tool106,spacer102 is inserted between adjacent vertebrae.Gap176 is sufficiently large betweenplate104 andinsertion tool106 to allow securing devices, such as, for example, screws (not shown) to be inserted through through-holes160,162, and into inferior vertebra and superior vertebra, respectively, securingplate104 to the vertebrae. After securingplate104 to the vertebrae,insertion tool106 is removed, leavingspacer102 andplate104, as separate components, in the patient's spinal column. While theplate104 andspacer102 are attached to theinsertion tool106 upon delivery to a surgical site, once theinsertion tool106 is removed, theplate104 andspacer102 can be viewed as decoupled or independent from one another.

An alternative embodiment of an intervertebral spacer and plate assembly200 (“assembly200”) is shown inFIGS. 20-28. In an exemplary embodiment,assembly200 can be used for lumbar repair, although those skilled in the art will recognize thatassembly200 can be sized for thoracic or cervical repair as well.

Assembly200 is formed from two separate components, an intervertebral spacer202 (“spacer202”) and a plate204 (“plate204”). In some embodiments,spacer202 andplate204 are not connected to each other, but are instead each separately coupled to aninsertion tool206, as shown inFIGS. 25-28.

Referring toFIGS. 20 and 22-24,spacer202 includes abody208 having asuperior surface210 and an opposinginferior surface212. Each ofsuperior surface210 andinferior surface212 can have a plurality of protrusions orfixation elements214 extending outwardly therefrom. Whilefixation elements214 are shown as being generally pyramidal in shape, those skilled in the art will recognize thatfixation elements214 can be other shapes, such as ribbed, or other suitable shapes.Fixation elements214 are used to bite into a grip each of adjacent vertebrae (not shown) between which spacer202 is inserted.

As shown inFIG. 20,body202 can have a generally oblong shape, with generally arcuatelateral sides216,218, connected to each other by ananterior portion220 and aposterior portion222.Lateral side216 includes anindentation217 whilelateral side218 includes asimilar indentation219.Indentations217,219 reduce the lateral length ofposterior portion222 relative to the remaining lateral length ofspacer202. Aspace223 bounded bylateral sides216,218,anterior portion220, andposterior portion222 can optionally be filled with graft material.

Posterior portion222 includes a firstchamfered face224 that extends in an inferior direction posteriorly fromsuperior surface210 and a second chamfered face226 (shown inFIG. 23) that extends in a superior direction posteriorly frominferior surface212. Chamfered faces224,226 allow for securing screws (not shown) to be inserted throughplate204, along chamfered faces224,226, respectively, and into adjacent vertebrae (not shown) without engagingspacer202.

Posterior portion222 also includes a smooth, anteriorly directedhole228 proximate tolateral side216.Hole228 is sized to accept a non-threaded portion ofinsertion tool206 as will be explained in detail below.Posterior portion222 also includes a threaded, anteriorly directedhole229 proximate tolateral side218.Hole229 is sized to accept a threaded portion ofinsertion tool206 as will be explained in detail below.

Referring now toFIGS. 20-24,plate204 includes abody230 having asuperior surface232 and an opposinginferior surface234. Each ofsuperior surface232 andinferior surface234 can have a plurality ofstabilizer elements236 extending outwardly therefrom. In some embodiments, thestabilizer elements236 can be for torsional stabilization. In an exemplary embodiment,stabilizer elements236 are located alongfingers238,240 that extend anteriorly fromplate204. Whilestabilizer elements236 are shown as being generally ribbed in shape, those skilled in the art will recognize thatstabilizer elements236 can be other shapes, such as pyramidal, or other suitable shapes.Stabilizer elements236 are used to bite into a grip each of adjacent vertebrae (not shown) between which spacer202 is inserted.

As shown inFIG. 20,body230 can have a generally laterally elongate shape, with generally parallellateral sides242,244.Fingers238,240 extend fromlateral sides242,244, respectively.Fingers238,240 are sized to fit intoindentations217,219 respectively, while a space betweenfingers238,340 is sized to allowposterior portion222 ofspacer202 to be inserted therein.

Referring toFIG. 21, through-holes260,262 extend throughbody230 in a posterior-to-anterior direction. Through-holes260,262 are located onplate204 to align withholes228,229 whenplate204 andspacer202 are coupled as shown inFIG. 20. Through-hole260 can be smooth bored to allow for the passage of the non-threaded portion ofinsertion tool206. Through-hole262 can be smooth bored or threaded to allow for the insertion of the threaded portion ofinsertion tool206.

Additional through-holes264,266,268 are provided inplate204 and are sized to allow a securing screw (not shown) to be inserted therethrough to secureplate204 to each of a superior vertebra (not shown) and an inferior vertebra (not shown), between which spacer202 is being inserted. Through-holes264,266 each extends in a superior-to-inferior direction so that their respective screw each engages and secures to the inferior vertebra, while through-hole268 extends in an inferior-to-superior direction so that its screw engages and secures the superior vertebra.

Referring toFIG. 21, lockingscrews270,272,274 are each is disposed adjacent to a respective through-hole264,266,268. Each lockingscrew270,272,274 has a head276,278,280 with anarcuate cutout282,284,286, respectively, that is sized to allow the securing screws discussed above to be inserted into through-holes264,266,268. During insertion ofassembly200, lockingscrews264,266,268 are in a configuration relative to plate204 as shown inFIG. 21. After the securing screwssecure plate204 to the superior and inferior vertebra, lockingscrews270,272,274 are rotated, for example, about 90 degrees, so that heads276,278,280 each extends over its adjacent securing screws, preventing the securing screws from inadvertently backing out.

FIGS. 20-24, 27, and 28show assembly200. Whileplate204 is butted up againstspacer202 to form a coupled construct,plate204 is not connected to spacer202 so thatspacer202 andplate204 remain separate, independent components that can be implanted together or on their own as part of a fusion procedure.

Referring now toFIGS. 25-28,insertion tool206 is used to insertspacer202 andplate204.Insertion tool206 includes adistal end282 having a firstdistal finger284 and a seconddistal finger286 that extends generally parallel to firstdistal finger282. Firstdistal finger282 is a generally smooth bore rod that is sized to pass through through-hole260 inplate204 and intohole228 inspacer202.

Seconddistal finger286 includes a rod288 having a threadedend290 that threads into threaded through-hole262 inplate204, as shown inFIG. 25, as well as intohole229 in spacer, as shown inFIG. 27. Rod288 has a proximal end (not shown) that can be rotated by the surgeon to threadingly secure threadedend290 intohole229.

While asingle insertion tool206 is shown, those skilled in the art will recognize that multiple insertion tools can be used. For example, a first insertion tool having only firstdistal finger282 can be used in conjunction with a second insertion tool having only seconddistal finger286.

According to one embodiment, a method of installingassembly200, for example, at the site of two adjacent vertebrae (not shown), may include providingspacer202,plate204, andinsertion tool206 as a kit, as shown inFIG. 28.

As shown inFIGS. 23 and 24,plate204 is releasably engaged withspacer202 in the absence of securingplate204 to spacer202 such thatplate204 engagesspacer202 betweenfirst finger238 andsecond finger240, as shown inFIG. 20.

Next,insertion tool206 is inserted throughplate204 and intospacer202. Such insertion is performed by insertinginsertion tool206 through first through-hole260 and second through-hole262 and intoholes228,230 ofspacer202. This is accomplished by threading threadedfinger286 ofinsertion tool206 intoplate204 and intohole229 inspacer202, as well as insertingunthreaded finger282 ofinsertion tool206 throughplate204 and intohole228 inspacer202.

Next,spacer202 is implanted between adjacent vertebrae.Insertion tool206 is removed such thatspacer202 is separate fromplate204. Next,plate204 is connected to the vertebrae.

Optionally, as shown inFIGS. 25 and 26,insertion tool206 can be releasably secured toonly plate204. Then,plate204 can be coupled tospacer202, after whichtime insertion tool206 is then releasably secured tospacer202.

A situation may arise whereinplate204 is not required to securespacer202 between adjacent vertebrae; the compression of vertebrae toward each other is sufficient to maintainspacer202 in place. In such a situation,plate204 can be omitted. It is desired, however, to incorporate a substitute forplate204 in order to provide desired spacing betweenplate202 andinsertion tool206.

To achieve this spacing, as shown inFIGS. 29 and 30, aspacer block290 is provided.Spacer block290 has substantially the same anterior-to-posterior width asplate204, but withoutfingers238,240.Spacer block290 includes a pair of unthreaded, smooth bore through-holes292,294 that align withholes228,230 ofspacer202 so thatfingers282,286 ofinsertion tool206 can be inserted therethrough and intohole228,230 ofspacer202 for insertion ofspacer202 between adjacent vertebrae (not shown).

An alternative embodiment of an intervertebral spacer and plate assembly300 (“assembly300”) is shown inFIGS. 31-39. In an exemplary embodiment,assembly300 can be used for lumbar repair, although those skilled in the art will recognize thatassembly300 can be sized for thoracic or cervical repair as well.

Assembly300 is formed from two separate components, an intervertebral spacer302 (“spacer302”) and a plate304 (“plate304”). In some embodiments,spacer302 andplate304 are not connected to each other, but are instead each separately coupled to aninsertion tool306, as shown inFIGS. 38 and 39.

Referring toFIGS. 31 and 34-35,spacer302 is similar tospacer202, but, instead of asolid posterior portion222,posterior portion322 ofspacer302 includes agap325 between two medially directed ends324,326.Gap325 allows forspacer302 to flex after insertion, which may provide enhanced mobility for the patient.

Additionally,spacer302 includesindentations317,319 that are larger thanindentations217,219 onspacer202. Similarly,fingers338,340 onplate304 are wider thanfingers238,240 onplate204 to accommodate thelarger indentations317,319.

Other aspects ofspacer302,plate304, andinsertion tool306 are similar, if not identical, to corresponding aspects ofspacer202,plate204, andinsertion tool206 as discussed above. Those aspects are identified with element numbers corresponding to spacer202,plate204, andinsertion tool206 with respect tospacer302,plate304, andinsertion tool306, respectively.

With respect to aspacer block390 shown inFIGS. 40 and 41, however, spacerblock390 includes fingers396,398 that are insertable intoindentations317,319. Other aspects ofspacer block390 are similar, if not identical, to corresponding aspects ofspacer block290 as discussed above.

Instead ofplate304, analternative plate304′, shown inFIGS. 41A-41D can be provided. Plate304′ is similar toplate304, with the addition of asuperior extension393 on theposterior end394 ofplate304′.Extension393 increases the overall height ofplate304′ and allowsplate304′ to be shouldered onto the vertebral body during insertion. As shown inFIG. 41B,extension393 can be straight. Alternatively,extension393 can be angled in a posterior direction.

An alternative embodiment of an intervertebral spacer and plate assembly400 (“assembly400”) is shown inFIGS. 42-50. In an exemplary embodiment,assembly400 can be used for lumbar repair, although those skilled in the art will recognize thatassembly400 can be sized for thoracic or cervical repair as well.

Assembly400 is formed from two separate components, an intervertebral spacer402 (“spacer402”) and a plate404 (“plate404”). In some embodiments,spacer402 andplate404 are not connected to each other, but are instead each separately coupled to aninsertion tool406, as shown inFIGS. 47 and 48. Upon delivery to a surgical site, thespacer402 andplate404 can be decoupled from one another.

Referring toFIGS. 42-47,spacer402 is similar tospacer302, but, instead ofholes260,262 for insertion ofinsertion tool306,lateral sides416,418 include arecess460,462, respectively.Recesses460,462 extend anteriorly fromindentations317,319 toward anterior face456. Eachrecess460,462 includes a plurality of superior-to-inferior extendingslots464.FIGS. 45 and 46 show twoslots464 in eachrecess460,462, although those skilled in the art will recognize that more or less than twoslots464 can be provided.

Additionally,fingers338,340 onplate404 each include arecess438,440, respectively that extend in an anterior-to-posterior direction along the length of eachrespective finger338,340. Eachrecess438,440 includes a plurality of superior-to-inferior extendingslots464.FIGS. 45 and 46 show twoslots442 in eachrecess438,440, although those skilled in the art will recognize that more or less than twoslots442 can be provided.

Other aspects ofspacer402 andplate404 are similar, if not identical, to corresponding aspects ofspacer302 andplate304 as discussed above. Those aspects are identified with element numbers corresponding to spacer302 andplate304 with respect tospacer402 andplate404, respectively.

Insertion tool406 is shown inFIGS. 47-52.Insertion tool406 includes a distal end470 having a firstdistal finger472 and a seconddistal finger474 that extends generally parallel to firstdistal finger474. A gap betweenfingers472,474 forms a generallyU-shaped cavity476 that is sized to acceptplate404 therein, as shown inFIGS. 47 and 48. Firstdistal finger472 includes a plurality ofprotrusions478 that fit intorecess460 andslots464 onspacer402 andrecess438 andslots442 onplate404. Similarly, seconddistal finger474 includes a plurality ofprotrusions480 that fit intorecess462 andslots464 onspacer402 andrecess440 andslots442 onplate404.

A proximal end (not shown) ofinsertion tool406 can include a pivot connection such that the opening ofinsertion tool406 at the proximal end splays firstdistal finger472 away from seconddistal finger474 to releasespacer402 andplate404 so thatspacer402 andplate404 are separated components.

Referring toFIGS. 51 and 52,spacer block490 includesslots492 that receiveprotrusions478,480 oninsertion tool406. Other aspects ofspacer block490 are similar, if not identical, to corresponding aspects ofspacer block390 as discussed above.

An alternative embodiment of an intervertebral spacer and plate assembly500 (“assembly500”) is shown inFIGS. 53-63. In an exemplary embodiment,assembly500 can be used for lumbar repair, although those skilled in the art will recognize thatassembly500 can be sized for thoracic or cervical repair as well.

Assembly500 is formed from two separate components, an intervertebral spacer502 (“spacer502”) and a plate504 (“plate504”). In some embodiments,spacer502 andplate504 are not connected to each other, but are instead each separately coupled to aninsertion tool506, as shown inFIGS. 58 and 59.

Assembly500 is similar toassembly400 except that, instead of havinggap325 between two medially directed ends324,326,spacer502 has aposterior portion525 that extends fully betweenlateral sides516,518.Lateral sides516,518 includeindentations517,519 that do not extend medially as far asindentations317,319 respectively, formed inspacer402, as discussed above.

Additionally, referring toFIGS. 62 and 63, aspacer block590 includesslots592 that receiveprotrusions478,480 on an insertion tool4506.

An alternative embodiment of an intervertebral spacer and plate assembly600 (“assembly600”) is shown inFIGS. 64-67. In an exemplary embodiment,assembly600 can be used for lumbar repair, although those skilled in the art will recognize thatassembly600 can be sized for thoracic or cervical repair as well.

Assembly600 is formed from two separate components, an intervertebral spacer602 (“spacer602”) and a plate604 (“plate604”).Plate704 is shown in detail inFIGS. 75-78.Plate602 has abody610 having a generally arcuate shape, with generally parallellateral sides612,614. Aposterior portion616,618, respectively, of eachlateral side612,614 includes an anterior-to-posterior recess620,622, respectively. Eachrecess620,622 includes a laterally projectingprotrusion624 having sloped superior and inferior sides (only oneprotrusion624 is shown inFIG. 65). Eachrecess620,622 is in communication with aslot628,630, respectively that each extends medially. Amedial portion628,629 of eachlateral side612,614, respectively, include anoblique cutout616,618.

Plate604 includes abody630 having a generally laterally elongate shape, with generally parallellateral sides642,644.Fingers638,640 extend fromlateral sides642,644, respectively.Fingers638,640 are sized to fit intorecesses620,622, respectively, inspacer602. As shown inFIG. 65,finger638 includes acutout646 formed therein. Although not shown,finger640 includes a corresponding cutout. An anterior end of eachfinger638,640 includes amedially extending prong648,650 that fits into aslot628,630, respectively. An anterior face652 ofbody630 also includes two spaced apart tangs654,656.

Referring toFIG. 66, through-holes664,666,668 are provided inplate604 and are sized to allow a securing screw (not shown) to be inserted therethrough to secureplate604 to each of a superior vertebra (not shown) and an inferior vertebra (not shown), between which spacer602 is being inserted. Through-holes664,666 each extends in a superior-to-inferior direction so that their respective screw each engages and secures to the inferior vertebra, while through-hole668 extends in an inferior-to-superior direction so that its screw engages and secures the superior vertebra.

Lockingscrews670,672 are each is disposed between respective through-holes664,666,668. Each lockingscrew670,672 has ahead676 with a pair ofarcuate cutouts682,684 that are sized to allow the securing screws discussed above to be inserted into through-holes664,666,668. During insertion ofassembly600, lockingscrews664,666,668 are in a configuration relative to plate604 as shown inFIG. 66. After the securing screwssecure plate604 to the superior and inferior vertebra, lockingscrews670,672 are rotated, for example, about 90 degrees, so that heads676,678 each extends over its adjacent securing screws, preventing the securing screws from inadvertently backing out. In some embodiments, the locking screws670,672 (upon rotation) can abut a side of the securing screws to prevent inadvertent backing out.

Assembly600 is fitted together by aligningfingers638,640 andprongs648,650 onplate604 withrecesses620,622 andslots628,630, respectively, onspacer602, which also aligns lateral sides oftangs654,656 withcutout616,618, respectively.Plate604 is slid down intospacer602, lockingfingers638,640 andprongs648,650 intorecesses620,622 andslots628,630, respectively.

Additionally,protrusion624 slides intocutout646.Tangs654,656 engagecutouts616,618, respectively, stabilizingplate604 with respect tospacer602.

Assembly600 is inserted between adjacent vertebrae as a unit, and, unlike other embodiments of the present invention, remain as a unit after implantation.

Another alternative embodiment of an intervertebral spacer and plate assembly700 (“assembly700”) is shown inFIGS. 68-82. In an exemplary embodiment, assembly700 can be used for cervical repair, although those skilled in the art will recognize thatassembly400 can be sized for thoracic or lumbar repair as well.

Assembly700 is formed from two separate components, an intervertebral spacer702 (“spacer702”) and a plate704 (“plate704”). In some embodiments,spacer702 andplate704 are not connected to each other, but are instead each separately coupled to an insertion tool similar toinsertion tool406, shown inFIGS. 47 and 48.

Referring toFIGS. 72-74,spacer702 is similar tospacer402, but, instead of havinggap325 between two medially directed ends324,326,spacer702 has aposterior portion725 that extends fully betweenlateral sides716,718.Recesses760,762 extend anteriorly fromposterior portion725 towardanterior face756. Eachrecess760,762 includes a plurality of superior-to-inferior extendingslots764.FIGS. 73 and 74 show twoslots764 in eachrecess760,762, respectively, although those skilled in the art will recognize that more or less than twoslots764 can be provided.

Posterior portion725 includescutouts728,730 to allow securing screws (not shown) to extend therethrough to secureplate704 to adjacent vertebrae (not shown). When viewed from a posterior-to-anterior direction, afirst cutout728 is formed in asuperior surface710 and is defined byside walls732,734 and abottom wall736. As shown inFIG. 72,side walls732,734 andbottom wall736 extend at oblique angles relative to each other, although those skilled in the art will recognize thatside walls732,734 can extend orthogonally tobottom wall736.

Similarly, a second cutout738 is formed in aninferior surface712 and is defined byside walls742,744 and atop wall746. As shown inFIG. 72,side walls742,744 andtop wall746 extend at oblique angles relative to each other, although those skilled in the art will recognize thatside walls742,744 can extend orthogonally totop wall746.

Plate704 is shown in detail inFIGS. 75-78.Plate704 has abody750 having a generally arcuate shape, with generally parallellateral sides752,754. Eachlateral side752,754 includes an anterior-to-posterior recess776,778, respectively. Eachrecess776,778 is in communication with aslot760,762 inspacer702.

Plate704 also includes through-openings782,784 for securing screws (not shown) that are used to secureplate704 to adjacent vertebrae (not shown). A lockingscrew786 can be rotated, for example, about 90 degrees after the securing screws have been inserted to keep the securing screws from backing out after insertion. Whenplate704 is aligned withspacer702 as shown inFIGS. 79-82, through-opening782 is aligned withfirst cutout728 inspacer702 and through-opening784 is aligned withsecond cutout730 inspacer702 so that the securing screws can pass over or underspacer702 and into their respective vertebrae.

Also, as shown inFIGS. 81 and 82, whenplate704 is aligned withspacer702 for insertion,recess776 is aligned withrecess760 andrecess778 is aligned withrecess762 so that an insertion tool, similar toinsertion tool406, can extend throughplate704 andgrip spacer702 for insertion.

The insertion procedure for assembly700 can be similar to that as is described above forassembly400. However, instead ofinsertion tool406 having protrusions that engageplate704, such protrusions can be omitted and assembly700 can rely on friction betweenplate704 andinsertion tool406, as well as betweenimplant702 andinsertion tool406.

An alternative embodiment of an intervertebral spacer and plate assembly800 (“assembly800”) is shown inFIGS. 83-98. In an exemplary embodiment,assembly800 can be used for cervical repair, although those skilled in the art will recognize thatassembly800 can be sized for thoracic or lumbar repair as well.

Assembly800 is formed from two separate components, an intervertebral spacer802 (“spacer802”) and a plate804 (“plate804”). In some embodiments,spacer802 andplate804 are not connected to each other, but instead merely engage each other.

Referring toFIGS. 84 and 86-89,spacer802 includes abody808 having asuperior surface810 and an opposinginferior surface812. Each ofsuperior surface810 andinferior surface812 can have a plurality offixation elements814 extending outwardly therefrom. Whilefixation elements814 are shown as being generally pyramidal in shape, those skilled in the art will recognize thatfixation elements814 can be other shapes, such as ribbed, or other suitable shapes.Fixation elements814 are used to bite into a grip each of adjacent vertebrae (not shown) between which spacer802 is inserted.

As shown inFIG. 20,body802 can have a generally oblong shape, with generally linearlateral sides816,818, connected to each other by ananterior portion820 and aposterior portion822, with a generally isosceles trapezoid interior space823 defined therebetween that can optionally be filled with graft material.

Posterior portion822 includes anarcuate face824 that extends betweenlateral sides816,818. Arounded protrusion826 extends posteriorly fromposterior portion822. A pair of insertion tool engagement holes828,829 are each located on opposing sides ofprotrusion826.Holes828,829 can be threaded or unthreaded, and can be through-holes or blind holes.Holes828,829 are sized to accept arms of an insertion tool (not shown) for insertion ofassembly800.

Referring now toFIGS. 85 and 90-93,plate804 includes abody830 having ananterior surface832 and an opposingposterior surface834. Referring toFIGS. 90 and 91,plate804 can have a generally “X” shape, with left and rightsuperior arms836,838, respectively, and left and rightinferior arms840,842, respectively.Superior arms836,838 include through-openings844,846 that are angled in a superior direction to allow screws (not shown) to be inserted therethrough to secureplate804 to a superior vertebra (not shown). Similarly,inferior arms840,842 include through-openings848,850 that are angled in an inferior direction to allow securing screws (not shown) to be inserted therethrough to secureplate804 to an inferior vertebra (not shown).

Referring toFIG. 90, locking screws852,854,856,858 are each disposed adjacent to a respective through-opening844,846,848,850. Each locking screw852,854,856,858 has ahead860 with anarcuate cutout862, respectively, that is sized to allow the securing screws discussed above to be inserted into through-openings844,846,848,850. During insertion ofassembly800, locking screws852,854,856,858 are in a configuration relative to plate804 as shown inFIG. 95. After the securing screwssecure plate804 to the superior and inferior vertebra, locking screws852,854,856,858 are rotated, for example, about 90 degrees, so thatheads860 each extends over its adjacent securing screws, preventing the securing screws from inadvertently backing out.

Plate804 also includes a centrally locatedposterior recess870. As shown inFIG. 90,recess870 can be generally oblong in shape, although those skilled in the art will recognize thatrecess870 can be other shapes.Recess870 accepts a prong on an insertion device (not shown) for insertion ofassembly800.

Referring toFIG. 91, anterior surface8732 ofplate804 includes a centrally locatedconcave recess874 that acceptsprotrusion826, as shown inFIG. 98.Protrusion826 rides withinrecess874, forming an articulating joint that allowsplate804 to pivot relative tobody802, providing some flexibility for the patient afterassembly800 is implanted.

FIGS. 83 and 95-98show assembly800. Whileplate804 is butted up againstspacer802 to form a coupled construct,plate804 is not rigidly connected to spacer802 so thatspacer802 andplate804 remain separate, independent components throughout insertion and after insertion into the patient.

An alternative embodiment of an intervertebral spacer and plate assembly900 (“assembly900”) is shown inFIGS. 99-113. In an exemplary embodiment,assembly900 can be used for cervical repair, although those skilled in the art will recognize thatassembly900 can be sized for thoracic or lumbar repair as well.

Assembly900 is formed from two separate components, anintervertebral spacer902 and aplate904.Spacer902 andplate904 are never connected to each other, but instead merely engage each other.

Referring toFIGS. 99 and 102-105,spacer902 includes abody908 having asuperior surface910 and an opposinginferior surface912. Each ofsuperior surface910 andinferior surface912 can have a plurality offixation elements914 extending outwardly therefrom. Whilefixation elements914 are shown as being generally pyramidal in shape, those skilled in the art will recognize thatfixation elements914 can be other shapes, such as ribbed, or other suitable shapes.Fixation elements914 are used to bite into a grip each of adjacent vertebrae (not shown) between which spacer902 is inserted.

As shown inFIG. 103,body902 can have a generally oblong shape, with generally linearlateral sides916,918, connected to each other by ananterior portion920 and aposterior portion922, with a generally isosceles trapezoid interior space923 defined therebetween that can optionally be filled with graft material.

Posterior portion922 includes anarcuate face924 that extends betweenlateral sides916,918. A generally centrally located insertiontool engagement hole928 extends throughposterior portion922.Hole928 can be threaded, as shown inFIG. 100, or unthreaded.Hole928 is sized to an insertion tool (not shown) for insertion ofassembly900.

A pair ofplate engagement slots931,932 are each located on opposing sides ofhole928.Slots931,932 are blind holes and are generally rectangular in shape, with rounded corners.Slots931,932 are sized to accept posterior protrusions fromplate904, as is discussed below.

Referring now toFIGS. 101 and 106-109,plate904 includes abody930 having ananterior surface933 and an opposingposterior surface934. Referring toFIGS. 108 and 109 and 91 plate can have a generally “rhomboid” shape, with a rightsuperior arm936 and a leftinferior arm940.Superior arm936 includes a through-opening944 that is angled in a superior direction to allow a screw (not shown) to be inserted therethrough to secureplate904 to a superior vertebra (not shown). Similarly,inferior arm940 includes a through-opening948 that is angled in an inferior direction to allow a securing screw (not shown) to be inserted therethrough to secureplate904 to an inferior vertebra (not shown).

Referring toFIG. 108, lockingscrews952,954 are each disposed adjacent to a respective through-opening944,948. Each lockingscrew952,954 has ahead960 with anarcuate cutout962, respectively, that is sized to allow the securing screws discussed above to be inserted into through-openings944,948. During insertion ofassembly900, lockingscrews952,954 are in a configuration relative to plate904 as shown inFIG. 108. After the securing screwssecure plate904 to the superior and inferior vertebra, lockingscrews952,954 are rotated, for example, about 90 degrees, so thatheads960 each extends over its adjacent securing screws, preventing the securing screws from inadvertently backing out.

Plate904 also includes a centrally located through-opening970. As shown inFIG. 108, through-opening970 can be generally circular in shape, although those skilled in the art will recognize that through-opening970 can be other shapes. Through-opening970 is unthreaded and allows an insertion device (not shown) to pass therethrough for engagement withhole928 inspacer902 for insertion ofassembly900.

Referring still toFIG. 108, aposterior surface972 ofplate904 includes a pair of diametricallyopposed slots974,976 that extend at an oblique angle away from through-opening970.Slots974,976 accept a prong of an insertion instrument (not shown) during implantation ofassembly900, allowing the insertion instrument to be placed intoslots974,976 so thatplate904 is held rigidly on the insertion instrument without being able to rotate.

Referring now toFIGS. 106, 107, and 109, an anterior surface980 ofplate904 includes a pair of diametrically opposed protrusions982,984 that are sized and located to fit intoplate engagement slots931,932. A posterior end of lockingscrews952,954 also extends outwardly fromplate engagement slots931,932 as well.

FIGS. 99 and 110-113show assembly900. Whileplate904 is butted up againstspacer902 to form a coupled construct,plate904 is not connected to spacer902 so thatspacer902 andplate904 remain separate components throughout insertion and after insertion into the patient.

FIGS. 114-116 show analternative plate1004 that can be used withspacer902 to form an assembly1000.Plate1004 has a generally rectangular shape with a centrally located through-opening1070. As shown inFIG. 114, through-opening1070 can be generally circular in shape, although those skilled in the art will recognize that through-opening1070 can be other shapes. Through-opening1070 is unthreaded and allows an insertion device (not shown) to pass therethrough for engagement withhole928 inspacer902 for insertion of assembly1000.

Plate1004 has left and right superior through-openings1044,1046 that are angled in a superior direction to allow screws (not shown) to be inserted therethrough to secureplate1004 to a superior vertebra (not shown). Similarly,plate1004 has left and right inferior through-openings1048,1050 that are angled in an inferior direction to allow securing screws (not shown) to be inserted therethrough to secureplate1004 to an inferior vertebra (not shown).

Lockingscrews1052,1054,1056,1058 are each disposed adjacent to a respective through-opening1044,1046,1048,1050. Each lockingscrew1052,1054,1056,1058 has ahead1060 with anarcuate cutout1062, respectively, that is sized to allow the securing screws discussed above to be inserted into through-openings1044,1046,1048,1050. During insertion of assembly1000, lockingscrews1052,1054,1056,1058 are in a configuration relative to plate1004 as shown inFIG. 114. After the securing screwssecure plate904 to the superior and inferior vertebra, lockingscrews1052,1054,1056,1058 are rotated, for example, about 90 degrees, so thatheads1060 each extends over its adjacent securing screws, preventing the securing screws from inadvertently backing out.

Aposterior surface1072 ofplate1004 also includes a pair of superior andinferior slots1074,1076 on opposing sides of through-opening1070.Slots1074,1076 accept a prong of an insertion instrument (not shown) during implantation of assembly1000, allowing the insertion instrument to be placed intoslots1074,1076 so thatplate1004 is held rigidly on the insertion instrument without being able to rotate.

Referring now toFIG. 117, an alternative embodiment of an intervertebral spacer and plate assembly1100 (“assembly1100”) is shown.Assembly1100 includes aspacer1102 and aplate1104.

Plate1102 has abody1108 that includes aposterior surface1110.Posterior surface1110 includes a central through-opening1112 that is sized to accept aninsertion instrument1106. Through-opening1112 is threaded to matchthreads1114 on adistal end1116 ofinsertion instrument1106.Posterior surface1110 also includes a pair ofconcave recesses1120,1122, one on either side of through-opening1112.

Plate1104 has abody1130 that includes ananterior surface1132 for mating withposterior surface1110 ofspacer1102.Body1130 includes a through-opening1134 that extends posteriorly-to-anteriorly through the center ofbody1130. Through-opening1134 has a larger diameter than through-opening1112 inspacer1102 to allowdistal end1116 ofinsertion instrument1106 to pass therethrough.

Anterior surface1132 ofbody1130 also includes a pair ofconvex protrusions1140,1142, one on either side of through-opening1134 that extend intorecesses1120,1122, respectively, whenplate1104 is butted againstspacer1102, forming a solid construct.

Referring now toFIG. 118, an alternative embodiment of an intervertebral spacer and plate assembly1200 (“assembly1200”) is shown.Assembly1200 includes aspacer1202 and aplate1204.

Plate1202 has abody1208 that includes aposterior surface1210.Posterior surface1210 includes acentral recess1212.Posterior surface1210 also includes a pair of threadedrecesses1220,1222, one on either side ofcentral recess1212.

Plate1204 includes abody1230 having ananterior surface1232. Aprotrusion1234 extends anteriorly fromanterior surface1232 and is sized to fit intocentral recess1212.Body1230 also includes a pair of lateral through-holes1236,1238 that extend throughbody1230 and align with threadedrecesses1220,1222 whenprotrusion1234 is inserted intocentral recess1212.

To insertassembly1200 into a patient, an insertion instrument (not shown) having two prongs is inserted through through-holes1236,1238 inplate1104 and threaded into threadedrecesses1220,1222 inplate1200.Assembly1200 is inserted intoplate1204 is secured to a patient, then the insertion tool is unthreaded from threadedrecesses1220,1222 and removed fromassembly1200.

Referring now toFIG. 119, an alternative embodiment of an intervertebral spacer and plate assembly1300 (“assembly1300”) is shown.Assembly1300 includes aspacer1302 and aplate1304.Spacer1302 includes abody1308 having acentral void1309 formed therein. Aposterior side1310 ofspacer1302 includes a pair of through-passages1312,1314 intovoid1309.

Plate1304 includes a pair offingers1320,1322, each of which extends into one of through-passages1312,1314 and intovoid1309. When two prongs of an insertion device (not shown) are inserted into through-passages1312,1314,fingers1320,1322 splay open, temporarily securingplate1304 tospacer1302 for insertion. After insertion, when the insertion device is removed, fingers “un-splay” so thatplate1304 is no longer secured tospacer1302 and spacer1302 andplate1304 are two separate entities.

Referring now toFIG. 119, an alternative embodiment of an intervertebral spacer and plate assembly1300 (“assembly1300”) is shown.Assembly1300 includes aspacer1302 and aplate1304.Spacer1302 includes abody1308 having acentral void1309 formed therein. Aposterior side1310 ofspacer1302 includes a pair of through-passages1312,1314 intovoid1309.

Plate1304 includes a pair offingers1320,1322, each of which extends into one of through-passages1312,1314 and intovoid1309. When two prongs of an insertion device (not shown) are inserted into through-passages1312,1314,fingers1320,1322 splay open, temporarily securingplate1304 tospacer1302 for insertion. After insertion, when the insertion device is removed, fingers “un-splay” so thatplate1304 is no longer secured tospacer1302 and spacer1302 andplate1304 are two separate entities.

Referring now toFIG. 120, an alternative embodiment of an intervertebral spacer and plate assembly1400 (“assembly1400”) is shown.Assembly1400 includes aspacer1402 and aplate1404.Spacer1402 includes abody1408. Aposterior side1410 ofspacer1302 includes a pair ofblind passages1412,1414 extending intobody1408. Each ofblind passages1412,1414 widens to a receivingportion1416,1418, respectively, in a posterior-to-anterior direction.

Plate1404 includes a pair of through-passages1420,1422 extending parallel to each other in a posterior-to-anterior direction such that, whenplate1404 is aligned withspacer1402,passage1420 aligns withpassage1412 andpassage1422 aligns withpassage1414.

Aninsertion device1406 includes two parallelhollow prongs1430,1432. Eachprong1430,1432 is split posteriorly into twohalf portions1430a,1430band1432a,1432b, eachportion1430a,1430b,1432a,1432bhaving a lip.

Whenprongs1430,1432 ofinsertion device1406 are inserted through through-passages1420,1422 and intoblind passages1412,1414, respectively, and rods (not shown) are inserted throughprongs1430,1432,prong half portions1430a,1430band1432a,1432bsplay apart so that the lips onprongs1430,1432 splay open and are retained within receivingportions1416,1418, respectively, temporarily securingplate1404 tospacer1402 for insertion. After insertion, when the insertion device is removed, fingers “un-splay” so thatplate1404 is no longer secured tospacer1402 and spacer1402 andplate1404 are two separate entities.

Referring now toFIG. 121, an alternative embodiment of an intervertebral spacer and plate assembly1500 (“assembly1500”) is shown.Assembly1500 includes aspacer1502 and aplate1504.Spacer1502 includes abody1508 having acentral void1509 formed therein. Aposterior side1510 ofspacer1502 includes a pair of through-passages1512,1514 intovoid1509.

Plate1504 includes parallel through-passages1516,1518 extending parallel to each other in a posterior-to-anterior direction such that, whenplate1504 is aligned withspacer1502,passage1516 aligns withpassage1412 and passage14221518 aligns withpassage1514.

Insertion device1506 includes a pair offingers1520,1522, each of which extends through one of through-passages1516,1518 and one of through-passages1512,1514 and intovoid1509. Eachfinger1520,1522 includes a laterally extendinglip1524,1526, respectively.

When two prongs of an insertion device (not shown) are inserted into through-passages1516,1518 and1512,1514, with the prongs on medial sides of each offingers1520,1522,fingers1520,1522 are biased laterally so thatlips1524,1526 engage the posterior wall ofvoid1509, temporarily securingplate1504 tospacer1502 for insertion. After insertion, when theinsertion device1506 is removed,fingers1520,1522 bias back toward each other so thatplate1504 is no longer secured tospacer1502 and spacer1502 andplate1504 are two separate entities.

Referring now toFIG. 122, an alternative embodiment of an intervertebral spacer and plate assembly1600 (“assembly1600”) is shown.Assembly1600 includes aspacer1602 and aplate1604.Spacer1602 includes abody1608. Aposterior side1610 ofspacer1602 includes ablind slot1612 extending intobody1608.Slot1612 includeslateral sidewalls1614,1616.

Plate1604 includes atab1620 sized to fit intoslot1612 with lateral space on either side oftab1620 to accommodatefingers1622,1624.Biased fingers1622,1624 are pivotally connected tospacer1604 with anterior ends1626,1628 having a plurality of laterally extendingfingers1630. Posterior ends1632,1634 offingers1622,1624 are engageable by an insertion device (not shown)

During insertion,fingers1622,1624 are againstlateral sidewalls1614,1616 ofslot1612 so thatplate1604 is engaged withspacer1602.Fingers1630 compress toward theirrespective fingers1622,1624, wedging spacer1604 intospacer1602. Afterassembly1600 is inserted, the insertion device is removed, allowingfingers1622,1624 to bias away from sidewalls1614,1616, respectively, releasing spacer1602 fromplate1604.

Referring now toFIGS. 123-125, an alternative embodiment of an intervertebral spacer and plate assembly1700 (“assembly1700”) is shown.Assembly1700 includes aspacer1702 and aplate1704.Spacer1702 includes a body1708 having acentral void1709 formed therein. Asuperior surface1710 ofspacer1702 includes acentral slot1712 extending along aposterior surface1714 to void1709. Similarly, aninferior surface1720 includes acorresponding slot1722.

Referring toFIG. 123,plate1704 includes aslot1730 extending along atop surface1732 thereof and aslot1734 extending along abottom surface1736 thereof.Plate1704 includes a pair ofscrew opening1740,1742 and a centrally located blockingscrew1744. An alternative embodiment of aplate1704′, shown inFIG. 124, usesmultiple blocking screws1740′,1744′, each for anindividual screw opening1740′,1742′, with lockingscrews1744′,1746′ disposed laterally away from a center ofplate1740′ to allowplate1740′ to be thinner thanplate1740 and still be able to secure screws (not shown) inscrew openings1740′,1742′.

FIG. 125 shows ininsertion device1706 gripping bothspacer1702 and eitherplate1704 orplate1704′.Insertion device1706 extends throughslots1730,1712 andslots1734,1722, securing spacer1702 andplate1704,1704′ to securingdevice1706. After insertion,insertion device1704 is slid posteriorly,decupling spacer1702 andplate1704,1704′.

Referring toFIGS. 126 and 127, an alternative embodiment of an intervertebral spacer and plate assembly1800 (“assembly1800”) is shown.Assembly1800 includes aspacer1802 and aplate1804.Spacer1802 includes abody1810 having aposterior portion1812.Posterior portion1812 includes aspace1814 that is sized to receiveplate1804.Plate1804 can be inserted intospace1814 from a posterior direction or from a superior direction.

Spacer1802 can include connections for an insertion device (not shown) similar to that disclosed with respect tospacer102, described above.Assembly1800 can be inserted as a unit and then, after insertion, the insertion device is removed andspacer1802 andplate1804 remain as separate components in the patient's spinal column.

Referring toFIGS. 128-130 an alternative embodiment of an intervertebral spacer and plate assembly1900 (“assembly1900”) is shown.Assembly1900 includes aspacer1902 and aplate1904 orplate1904′.Spacer1902 includes abody1910 having aposterior portion1912.Posterior portion1912 includes a threadedopening1914 that is sized to receive an insertion tool (not shown). Each ofplates1904,1904′ include a threadedconnection1920,1920′ extending therethrough. Threadedconnections1920,1920′ accept a threaded insertion device (not shown) that extends thoughplate1904,1904′ and into threadedopening1914 inplate1902. The threaded connection between the insertion device andspacer1902 andplate1904,1904′ can be loose to provide for articulation during insertion, similar to the movement of a joystick. Onceassembly1900 is inserted, the insertion device is removed, and spacer1902 andplate1904,1904′ remain as separate components in the patient's spinal column.

FIG. 131 is a top perspective view of a spacer and plate assembly according to a nineteenth embodiment. The spacer andplate assembly2000 comprises aspacer2002 and aplate2004. Thespacer2002 andplate2004 are advantageously configured to be delivered to a surgical site via an insertion tool. In the present embodiment, the insertion tool comprises a threaded coupling shaft2070 (shown inFIG. 136) that holds both thespacer2002 and theplate2004 thereon. Once delivered, the insertion tool can be removed, thereby leaving thespacer2002 andplate2004 in place. At the surgical site, thespacer2002 andplate2004 are left decoupled and unfixed to one another.

Thespacer2002 comprises abody2008 having asuperior surface2010 and aninferior surface2004, each having one ormore fixation elements2014 in the form of protrusions, pyramids, or ribbing. The one ormore fixation elements2014 advantageously serve to grip bone in an adjacent vertebral body. Thebody2008 of thespacer2002 comprises ananterior portion2020 and aposterior portion2022 separated bylateral sides2016,2018. In some embodiments, thebody2008 comprises a c-shape, wherein thelateral sides2016,2018 form curved arms that surround aninner space2023 for receiving graft material therein. Theinner spacer2023 is surrounded by an inner wall orsurface2027 that curves along an interior of thespacer2002.

As shown inFIG. 131, abore2026 is formed along theinner surface2027. In some embodiments, thebore2026 is a threaded bore. The threadedbore2026 is configured to receive a threadeddistal end2072 of acoupling shaft2070 of an insertion tool (shown inFIG. 136). In some embodiments, the threadedbore2026 extends from theinner surface2027 completely though theanterior portion2020 of thespacer2002, while in other embodiments, the threadedbore2026 extends from theinner surface2027 only partially through theanterior portion2020 of thespacer2002.

As shown inFIG. 131, thebody2008 of thespacer2002 includes first and second recesses orindentations2017,2019.Indentation2017 is formed alonglateral side2016, whileindentation2019 is formed alonglateral side2018. Theindentations2017,2019 serve to receivefingers2038,2040 of theplate2004, as shown inFIG. 136. Theindentations2017,2019 advantageously help to stabilize thespacer2002 andplate2004 relative to one another when they are operatively coupled via the insertion tool. Thespacer2002 can be formed of both synthetic and natural material. In some embodiments, thespacer2002 is formed of bone, PEEK or titanium.

Theplate2004 comprises abody2030 having asuperior surface2032 and aninferior surface2034. Portions of thesuperior surface2032 andinferior surface2034 includestabilizer elements2036. In some embodiments, the stabilizer elements comprise protrusions, pyramids, or ribbing that are advantageously designed to provide torsional stabilization.

Theplate2004 further comprises a posterior portion comprising through-holes2064,2066,2068 for receiving fasteners therein. In the present embodiment, theplate2004 further includes lockingscrews2070,2072,2074, each associated with one of the through-holes2064,2066,2068. The locking screws2070,2072,2074 each have cut-away regions that allow for entry or removal of fasteners through theplate2004 in one configuration, but prevent backout of the fasteners when rotated into a second configuration. In some embodiments, theplate2004 further comprises a pair ofnon-threaded bores2044,2046, each of different sizes.Non-threaded bore2044 is configured to receiveextension2063 of insertion tool2006 (shown inFIG. 140A), whilenon-threaded bore2044 is configured to receivecoupling shaft2070 of insertion tool2006 (also shown inFIG. 140A).Non-threaded bore2044 comprises a partial bore that is not fully enclosed.Non-threaded bore2044 borders through-hole2064.Non-threaded bore2046 comprises a full bore that is fully enclosed. In some embodiments,non-threaded bore2046 comprises a square, while in other embodiments,non-threaded bore2046 comprises a square with rounded corners or edges.

Theplate2004 further comprises a pair of arms orfingers2038,2040 extending from the posterior portion of theplate2004. Thefingers2038,2040 comprise extensions that are configured to be received in theindentations2017,2019 of thespacer2002 when theinsertion tool2006 holds them together. In some embodiments, thefingers2038,2040 are configured to includestabilizer elements2036 thereon. Advantageously, thefingers2038,2040 of theplate2004 are configured to abut surfaces of thespacer2002 without tightly gripping thespacer2002, thereby allowing thespacer2002 to be decoupled from theplate2004 upon delivery to a surgical site. By providing a decoupledplate2004 andspacer2002, each can advantageously be delivered on their own, or together via an insertion tool. In some embodiments, theplate2004 further compriseswindows2039, which are formed on each of thefingers2038,2040. Thewindows2039 advantageously provide surgeons openings for visualization, so that they can confirm fusion is taking place.

FIG. 132 is a top view of the assembly shown inFIG. 131. From this view, one can see the contours of thespacer2002 andplate2004. In some embodiments, thespacer2002 comprises a c-shaped member having aspace2023 for receiving graft material therein. In some embodiments, theplate2004 comprisesfingers2036,2038 configured to be received inindentations2017,2019 of thespacer2002. As shown inFIG. 132, thefingers2036,2038 have rounded edges that are configured to abut surfaces of thespacer2002.

FIG. 133 is a side view of the assembly shown inFIG. 131. From this view, one can the side contours of thespacer2002 andplate2004. In some embodiments, thespacer2002 comprises one ormore chamfers2029 that allow for clearance of bone fasteners or screws that are inserted through theplate2004. In some embodiments, thespacer2002 comprises a pair ofchamfers2029, one found on each of thelateral sides2016,2018 of thespacer2002. In some embodiments, theplate2004 comprises one ormore windows2039 that provide for visualization. In some embodiments, thewindows2039 are circular. In other embodiments, thewindows2039 are non-rounded, such as square or rectangular.

FIG. 134 is a posterior view of the assembly shown inFIG. 131. From this view, one can see the through-holes2064,2066,2068 formed in theplate2004 for receiving bone fasteners or screws therein. In some embodiments, the through-holes2064,2066 are configured to receive bone fasteners in a downward direction, while through-hole2068 is configured to receive a bone fastener in an upward direction. Each of the through-holes2064,2066,2068 is associated with alocking screw2070,2072,2074 with cut-away regions. In some embodiments, lockingscrews2070,2074 are positioned adjacentnon-threaded bore2044, while lockingscrew2072 is positioned adjacentnon-threaded bore2046.

FIG. 135 is a posterior view of the spacer shown inFIG. 131. Thespacer2002 comprises an innercurved wall2027 that forms a perimeter aroundinner space2023. Along theinner wall2023 is formed a threadedbore2026 for receiving acoupling shaft2070 of an insertion tool2006 (shown inFIG. 136).

FIG. 136 is a top perspective view of the assembly shown inFIG. 131 attached to an insertion tool. In the present figure, theinsertion tool2006 is provided with break lines to show internal details. One skilled in the art will appreciate that theinsertion tool2006 does not have such break lines in operation, and that the break lines are to aid in the description of theinsertion tool2006. Theinsertion tool2006 comprises anouter shaft2060 that is coupled to anabutting end2062 on one end and ahandle2064 on the other end.

Theouter shaft2060 comprises a hollow interior that is configured to receive acoupling shaft2070 therein. Thecoupling shaft2070 comprises a shaft having a threadeddistal end2072. Thecoupling shaft2070 is configured to extend through thenon-threaded bore2046 in the plate2004 (shown inFIG. 131) before extending through the threadedbore2026 of the spacer2002 (also shown inFIG. 131). Thecoupling shaft2070 advantageously operatively couples thespacer2002 andplate2004 during delivery to a surgical site. In some embodiments, thecoupling shaft2070 can be received in aproximal opening2068 of theinsertion tool2006, as shown inFIG. 136. A driver (e.g., a hex driver) can be used to rotate thecoupling shaft2070. This rotation allows thecoupling shaft2070 to threadingly mate with the threadedbore2026 of thespacer2002.

Theabutting end2062 of theinsertion tool2006 comprises a distal end of theinsertion tool2006. Theabutting end2062 of theinsertion tool2006 is capable of abutting theplate2004. As shown inFIG. 140B,extension2063 andcoupling shaft2070 can extend outwardly from theabutting end2062.

Thehandle2064 of theinsertion tool2006 comprises a gripping surface. A surgeon is capable of gripping thehandle2064 and rotating thecoupling shaft2070 within theinsertion tool2006. In some embodiments, thehandle2064 comprises aproximal opening2068 for receiving thecoupling shaft2070 therethrough.

FIG. 137 is a top view of the assembly shown inFIG. 131 attached to an insertion tool. From this view, one can see how theouter shaft2060 of theinsertion tool2006 and thus, thecoupling shaft2070, are offset from a middle axis of thespacer2002 andplate2004.

FIG. 138 is a side view of the assembly shown inFIG. 131 attached to an insertion tool. From this view, one can see how thespacer2002 andplate2004 are inserted into a surgical site. Thespacer2002 comprises a tapered leading end that aids in insertion of the assembly.

FIG. 139 is a bottom view of the assembly shown inFIG. 131 attached to an insertion tool. From this view, one can see how thespacer2002 is chamfered on each of itslateral sides2016,2018, thereby providing clearance for bone screws or fasteners that are inserted through theplate2004.

FIGS. 140A-140C illustrate the insertion tool being attached to the spacer and plate assembly in accordance with some embodiments.FIG. 140A illustrates theinsertion tool2006 prior to insertion of thecoupling shaft2070 in theouter shaft206.FIG. 140B illustrates theinsertion tool2006 with thecoupling shaft2070 inserted in theouter shaft206. In the present figure, theinsertion tool2006 is not yet engaged with theplate2004 orspacer2002.FIG. 140C illustrates theinsertion tool2006 engaged with theplate2004 via thecoupling shaft2070, but not yet engaged with thespacer2002. While not shown inFIGS. 140A-140C, the threadeddistal end2072 of thecoupling shaft2070 will engage the threadedbore2026 of thespacer2002, thereby operatively coupling thespacer2002 andplate2004 during delivery to a disc space. Once delivered, bone fasteners can be inserted into theplate2004 to thereby fix theplate2004 to one or more adjacent vertebrae. Theinsertion tool2006 can then be removed. Upon removal of theinsertion tool2006, theplate2004 andspacer2002 are left in the surgical site, uncoupled to one another.

FIG. 141 is a top perspective view of a spacer and plate assembly according to a twentieth embodiment. The spacer andplate assembly2100 comprises aplate2104 havingnovel gripping components2142 that are designed to have a first “neutral” configuration whereby aspacer2102 is ungripped and a second “non-neutral” configuration whereby aspacer2102 is gripped. While in this second configuration, an insertion tool can advantageously deliver thespacer2102 andplate2104 together into a surgical site. Once at the surgical site, thespacer2102 andplate2104 can be decoupled by changing thegripping components2142 back to the first neutral configuration.

The spacer andplate assembly2100 comprises aspacer2102 and aplate2104. Thespacer2102 comprises abody2108 having asuperior surface2110 and aninferior surface2104, each having one ormore fixation elements2114 in the form of protrusions, pyramids, or ribbing. The one ormore fixation elements2114 advantageously serve to grip bone in an adjacent vertebral body. Thebody2108 of thespacer2102 comprises ananterior portion2120 and aposterior portion2122 separated bylateral sides2116,2118. In the present embodiment, thebody2108 comprises an enclosed d-shape, wherein thelateral sides2116,2118 form curved arms that surround aninner space2123 for receiving graft material therein. Theinner spacer2123 is surrounded by an inner wall orsurface2127 that curves along an interior of thespacer2102.

As shown inFIG. 131, thebody2108 of thespacer2102 includes first and second recesses orindentations2117,2119.Indentation2117 is formed alonglateral side2116, whileindentation2119 is formed alonglateral side2118. Theindentations2117,2119 serve to receivefingers2138,2140 of theplate2104, as shown inFIG. 142. Theindentations2117,2119 advantageously help to stabilize thespacer2102 andplate2104 relative to one another when they are operatively coupled via the insertion tool. Thespacer2102 can be formed of both synthetic and natural material. In some embodiments, thespacer2102 is formed of bone, PEEK or titanium.

Theplate2104 comprises a body2130 having asuperior surface2132 and aninferior surface2134. Portions of thesuperior surface2132 andinferior surface2134 includestabilizer elements2136. In some embodiments, the stabilizer elements comprise protrusions, pyramids, or ribbing that are advantageously designed to provide torsional stabilization.

Theplate2104 further comprises a posterior portion comprising through-holes2164,2166,2168 for receiving fasteners therein. In the present embodiment, theplate2104 further includes locking screws that are received inopenings2171,2173. The locking screws each have cut-away regions that allow for entry or removal of fasteners through theplate2104 in one configuration, but prevent backout of fasteners when rotated into a second configuration. In some embodiments, the posterior portion of theplate2104 comprisesrecesses2145,2147 that are configured to receivegripping components2140,2142 therein. Thegripping components2140,2142 comprise c-shapedbodies having slots2144,2146 formed therein. Theslots2144,2146 enable to thegripping components2140,2142 to be compressed and received in therecesses2145,2147. Thegripping components2140,2142 are capable of being in a neutral configuration (shown inFIG. 146A), whereby thespacer2102 is not compressed. Thegripping components2140,2142 are further capable of being in a non-neutral configuration (shown inFIG. 147A), whereby thespacer2102 is compressed. In the neutral configuration, theplate2104 is not coupled to thespacer2102, while in the non-neutral configuration, theplate2104 is coupled to thespacer2102. Accordingly, by providing these configurations, a surgeon can advantageously choose to deliver thespacer2102 andplate2104 to a surgical site together or separately one at a time, depending on the needs of a patient.

One or more holders, instruments or tools can move thegripping components2140,2142 from a neutral configuration to a non-neutral configuration. In some embodiments, the grippingcomponents2140,2142 permit theplate2104 to grip thespacer2102 temporarily. In some embodiments, a single holder or insertion tool can be inserted into thespaces2147,2149 adjacent thegripping components2140,2142 (shown inFIGS. 146A and 147A), thereby moving thegripping components2140,2142 into a non-neutral configuration. In the non-neutral configuration, the grippingcomponents2140,2142 of theplate2104 apply compression on thespacer2102, thereby temporarily coupling theplate2104 to thespacer2102. With theplate2104 temporarily coupled to thespacer2102, the insertion tool can deliver theplate2104 and spacer2102 to a surgical site. One or more bone fasteners can be inserted into theplate2104 to attach theplate2104 to one or more adjacent vertebrae. With theplate2104 and spacer2102 in the surgical site, the insertion tool can be retracted from thespaces2147,2149, thereby allowing thegripping components2140,2142 to spring back into the neutral position. With thegripping components2140,2142 in the neutral position, theplate2104 is no longer coupled to thespacer2102.

Theplate2104 further comprises a pair of arms orfingers2138,2140 extending from the posterior portion of theplate2104. Thefingers2138,2140 comprise extensions that are configured to be received in theindentations2117,2119 of thespacer2102. In some embodiments, thefingers2138,2140 are configured to includestabilizer elements2136 thereon. Advantageously, thefingers2138,2140 of theplate2104 are configured to abut surfaces of thespacer2102 without tightly gripping thespacer2102, thereby allowing thespacer2102 to be decoupled from theplate2104 if desired upon delivery to a surgical site. By providing a decoupledplate2104 andspacer2102, each can advantageously be delivered on their own, or together via one or more insertion tools.

FIG. 142 is a top view of the assembly shown inFIG. 141. From this view, one can see how theinner space2123 of thespacer2102 is completed enclosed by theinner wall2127 of thespacer2102. In some embodiments, only a single throughhole2168 is upwardly angled.

FIG. 143 is a side view of the assembly shown inFIG. 141. From this view, one can see how the grippingcomponents2140,2142 are capable of being received in therecesses2145,2147 formed in theplate2104. In some embodiments, the grippingcomponents2140,2142 are capable of being snapped into theplate2104.

FIG. 144 is a bottom view of the assembly shown inFIG. 141. As shown in the figure, a pair of throughholes2164,2166 are downwardly angled.

FIG. 145 is a posterior view of the assembly shown inFIG. 141. From this view, one can see each of the throughholes2164,2166,2168 for receiving bone screws or fasteners, as well as the locking screws2170,2172 that help prevent back out of bone screws or fasteners from the throughholes2164,2166,2168. In some embodiments, lockingscrew2170 is adjacent throughholes2164,2168, while lockingscrew2172 is adjacent throughholes2166,2168.

FIGS. 146A-146C illustrate the spacer and plate assembly with the gripping features of the plate in a neutral position in accordance with some embodiments. In the neutral position, the grippingcomponents2140,2142 of theplate2104 are generally parallel to one another and do not compress thespacer2102. In this position, theplate2104 andspacer2102 are considered decoupled from one another. To move thegripping components2140,2142 into a non-neutral or compressed position, a holder or instrument is inserted into therecesses2147,2149 in the plate. The instrument is designed to press against the angled back surfaces of thegripping components2140,2142, which causes then to angle and compress thespacer2102.

FIGS. 147A-147C illustrate the spacer and plate assembly with the gripping features of the plate in a compressed position in accordance with some embodiments. In this non-neutral configuration, theplate2104 andspacer2102 are considered temporarily coupled to one another. To move thegripping components2140,2142 back to its neutral position, a holder or instrument simply needs to be retracted. A built in spring force will bring thegripping components2140,2142 back to the neutral position.

FIG. 148 is a top perspective view of a spacer and plate assembly according to a twenty-first embodiment. The spacer andplate assembly2200 comprises aspacer2202 and aplate2204. Thespacer2202 andplate2204 are configured to be delivered to a surgical site, for example, via an insertion tool2206 (shown inFIG. 153). In the present embodiment, theinsertion tool2206 comprises a holder2270 (shown inFIGS. 153-160) that holds both thespacer2202 and theplate2204 thereon. Once delivered, the insertion tool can be removed, thereby leaving thespacer2202 and theplate2204 in place. At the surgical site, thespacer2202 andplate2204 may be left decoupled and unfixed to one another.

Thespacer2202 comprises abody2208 extending along a centrallongitudinal axis2209 and having asuperior surface2210 and aninferior surface2212, each having one ormore fixation elements2214 in the form of protrusions, pyramids, teeth, ribbing, or other texture. The one ormore fixation elements2214 serve to grip bone in an adjacent vertebral body. Thebody2208 of thespacer2202 comprises ananterior portion2220 and aposterior portion2222 separated by first and secondlateral sides2216,2218. The firstlateral side2216 extends along a first side of thelongitudinal axis2209, while the secondlateral side2218 extends along an opposing side of thelongitudinal axis2209.

In some embodiments, thebody2208 comprises a “C” shape, wherein thelateral sides2216,2218 form curved arms that surround aninner space2223 for receiving graft material therein. Theinner space2223 is surrounded by an inner wall orsurface2227 that curves along an interior of thespacer2202.

In some embodiments, thespacer2202 comprises one ormore chamfers2229 that allow for clearance of bone fasteners or screws that are inserted through theplate2204. In some embodiments, thespacer2202 comprises a pair ofchamfers2229, one found on each of thelateral sides2216,2218 of thespacer2002.

Theinner surface2227 alonglateral side2216 includes aprong receiver2241 that is sized to receive aprong2294 of the holder2270 (shown inFIG. 156). Theprong receiver2241 is open to theinner space2223 of thebody2208 of thespacer2202.

As shown inFIGS. 148-150, arod receiver2226 is formed in theposterior portion2222 along thelateral side2218 and extends along anoblique axis2227 relative to thelongitudinal axis2209. In some embodiments, therod receiver2226 is a female threaded bore. In alternative embodiments, therod receiver2226 can be a smooth bore, with a separate threaded insert (not shown) inserted into thebore2226.

The female threadedrod receiver2226 is configured to receive a male threadeddistal end2274 of a threadedrod2272 of theholder2270. While a male and female threaded connection is shown, those skilled in the art will recognize that the male and female connection may be reversed or other types of connections, such as, for example, a quarter turn key-style lock, can be used to secure therod2272 to thespacer2202.

In some embodiments, the threadedrod receiver2226 extends from theposterior portion2222 only partially through thelateral side2218 of the spacer2202 (e.g., a blind hole). While in other embodiments (not shown), the threadedrod receiver2226 can extend completely through theanterior portion2020 of thespacer2002, and in other embodiments, the threadedbore2026 extends completely through thelateral side2218 of thespacer2202.

As shown inFIG. 150, thebody2208 of thespacer2202 includes first and second recesses orindentations2217,2219.Indentation2217 is formed along thelateral side2216, whileindentation2219 is formed along thelateral side2218. Theindentations2217,2219 serve to receivefingers2238,2240 of theplate2204. Theindentations2217,2219 help to stabilize thespacer2202 andplate2204 relative to one another when they are operatively coupled via theholder2270.Recesses2260,2262 in theindentations2217,2219, respectively, extend anteriorly fromposterior portion2222 toward theanterior portion2220. Therecesses2260,2262 are sized to accept prongs (not shown) on theplate2204 to stabilize the connection between thespacer2202 and theplate2204. Thespacer2202 andplate2204 can be formed of suitable biocompatible materials, including synthetic and natural materials. In some embodiments, thespacer2202 is formed of bone, PEEK or titanium, and theplate2204 is formed of titanium.

Theplate2204 comprises abody2230 having asuperior surface2232 and an inferior surface2234. Portions of thesuperior surface2232 and inferior surface2234 may includestabilizer elements2236. In some embodiments, the stabilizer elements may comprise protrusions, pyramids, or ribbing that are designed to provide torsional stabilization.

Theplate2204 further comprises a posterior portion comprising through-holes2264,2266,2268 for receiving fasteners therein. In the present embodiment, theplate2204 further includes lockingscrews2271,2273,2275, each associated with one of the through-holes2264,2266,2268. The locking screws2271,2273,2275 each have cut-away regions that allow for entry or removal of fasteners through theplate2204 in one configuration, but prevent backout of the fasteners when rotated into a second configuration. In some embodiments, theplate2204 further comprises a pair ofnon-threaded bores2244,2246, each of different sizes.Non-threaded bore2244 extends fully through theplate2204 and is configured to allow theprong2294 of theholder2270 to pass therethrough and into theprong receiver2241 in the spacer2202 (shown inFIG. 156), whilebore2246 is a rod opening that is configured to receive thedistal end2274 of therod2272 and allow thedistal end2274 of therod2272 to pass therethrough and into the spacer2202 (shown inFIG. 156).Non-threaded bore2244 is a prong opening that borders through-hole2264. In some embodiments, thenon-threaded bores2244,2246 each comprises a square, while in other embodiments, thenon-threaded bores2244,2246 each comprises a square with rounded corners or edges or, alternatively, can be other shapes, such as triangular, pentagonal, hexagonal, and the like. Both bores2244,2246 extend along anaxis2227 that is oblique to thelongitudinal axis2209 so that therod2272 in theholder2270 can pass through theholder2270 and engage both theplate2204 and thespacer2202 without interfering with or obstructing any graft material inserted into theinner space2223.

Theplate2204 further comprises a pair of arms orfingers2238,2240 extending from the posterior portion of theplate2204. Thefingers2238,2240 comprise extensions that are configured to be received in theindentations2217,2219 of thespacer2202 when theholder2270 holds them together. Advantageously, thefingers2238,2240 of theplate2204 are configured to abut surfaces of thespacer2202 without tightly gripping thespacer2202, thereby allowing thespacer2202 to be decoupled from theplate2204 upon delivery to a surgical site. By providing a decoupledplate2204 andspacer2202, each can advantageously be delivered on their own, or together via an insertion tool, such as theholder2270. Thefingers2238,2240 provide stability when theplate2204 is used without thespacer2202.

FIG. 149 is a posterior view of the assembly shown inFIG. 148. From this view, one can see the through-holes2264,2266,2268 formed in theplate2204 for receiving bone fasteners or screws therein. In some embodiments, the through-holes2264,2266 are configured to receive bone fasteners in a downward direction, while through-hole2268 is configured to receive a bone fastener in an upward direction.

FIG. 153 is a top perspective view of the assembly shown inFIG. 148 attached to theinsertion tool2206. Theinsertion tool2006 comprises theholder2270 and therod2272. Theholder2270 includes a holder body2280 having aproximal end2282, adistal end2284 having aplate engaging surface2286, amid portion2290 disposed between theproximal end2282 and thedistal end2284, and achannel2292 extending through theholder2270 between theproximal end2282 and thedistal end2284.

Theproximal end2282 of theholder2270 has a first width and themid portion2290 of theholder2270 has a second width, less than the first width such that themid portion2290 extends wholly on one side of thelongitudinal axis2209, as shown inFIG. 154. The size and location of themid portion2290 allows a user to grip theholder2270 and manipulate theholder2270 during insertion of theassembly2200.

Thechannel2292 has an arcuate, or curved, shape within thedistal end2284 in order for therod2272 to be able to curve within thechannel2292 and pass through therod opening2246 in theplate2204. To facilitate formation of the curved portion of thechannel2292, in an exemplary embodiment, theholder2270 is constructed from anupper portion2296 and a lower portion2298 (shown inFIG. 155), with thelower portion2298 being bonded to theupper portion2296 along abonding line2299. The curvature of thechannel2292 has a sufficiently large radius such that the amount of deflection of therod2272 is minimized, reducing frictional engagement of therod2272 within thechannel2292 as therod2272 is inserted through thechannel2292.

Aprong2294 extends distally from thedistal end2284. Theprong2294 is sized to extend through theprong opening2244 and into theprong receiver2241 to stabilize theassembly2200 on theinsertion tool2206 during insertion. Arod opening2295 is formed at thedistal end2284 and extends along an oblique angle relative to thelongitudinal axis2209 so that the rod opening aligns with therod opening2246 in theplate2204, allowing therod2270 to be inserted through thechannel2292 and therod opening2246, and into therod receiver2226.

The roddistal end2274 is sized to be inserted into theproximal end2282 of theholder2270, through thechannel2292 in theholder body2270, through therod opening2246 in theplate2204 and into thespacer2202 such that thedistal end2274 releasably engages therod receiver2226. Therod2272 may be constructed from an elastic metal such as, for example, Nitinol, which allows therod2272 to bend as therod2272 is advanced through thechannel2292.

Optionally, although not shown, theholder2270 can also include channels for anchors, as well as openings for screws to pass through for securing theplate2204 to vertebrae (not shown).

Theholder2270 advantageously operatively couples thespacer2202 andplate2204 during delivery to a surgical site. The engagingsurface2286 of thedistal end2284 of theholder2270 abuts theplate2204 so that theassembly2200 is securely connected to theinsertion tool2206.

FIG. 154 is a top view of theassembly2200 shown inFIG. 148 attached to theinsertion tool2206. From this view, one can see how themid portion2290 of theholder2270 is offset from thelongitudinal axis2209 of theassembly2200.

FIG. 155 is a side view of theassembly2200 shown inFIG. 148 attached to theinsertion tool2206. From this view, one can see how thespacer2202 andplate2204 are inserted into a surgical site. Thespacer2202 comprises a tapered leading end that aids in insertion of theassembly2200.

FIGS. 157-160 illustrate theinsertion tool2206 being attached to the spacer andplate assembly2200 in accordance with some embodiments.FIG. 157 illustrates theholder2270 prior to insertion of therod2272 into thechannel2292.FIG. 158 illustrates theinsertion tool2006 fully assembled with the rod22732 having been inserted into theholder2270.FIG. 159 illustrates theinsertion tool2206 engaged with theplate2204, but not yet engaged with thespacer2202.FIG. 160 illustrates thespacer2202 engaged with theholder2270, with the threadeddistal end2274 of therod2272 engaging the threadedbore2226 of thespacer2202, thereby operatively coupling thespacer2202 andplate2204 during delivery to a disc space.

Once delivered, theinsertion tool2206 can then be removed from theassembly2200 by unthreading therod2272 from thespacer2202 and removing theinsertion tool2206. Next, bone fasteners can be inserted into theplate2204 to thereby fix theplate2204 to one or more adjacent vertebrae. Theplate2004 andspacer2002 may be left in the surgical site, uncoupled to one another.

All of spacers102-2202 described above can be constructed from biocompatible material, such as, for example, bone, PEEK, titanium, with or without surface treatments, and with varying porosity.

In some embodiments, any of the plates and spacers described above can be accompanied by other surgical implants, including rods and screws. One of skill in the art will appreciate that any of the plates and spacers can be used on multiple levels of the spine.

It will be further understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated in order to explain the nature of this invention may be made by those skilled in the art without departing from the scope of the invention as expressed in the following claims.

Claims (12)

What is claimed is:

1. A spacer assembly extending along a longitudinal axis, the assembly comprising:

a spacer having:

a body having a first lateral side extending on one side of the longitudinal axis and a second lateral side extending on an opposing side of the longitudinal axis, with an inner space formed between the first and second lateral sides;

a prong receiver extending into the first lateral side; and

a rod receiver comprising a blind threaded hole extending along an axis oblique to the longitudinal axis into the second lateral side;

a plate having:

a plate body having a first finger adapted to engage the first lateral side and a second finger adapted to engage the second lateral side;

a prong opening located on the one side of the longitudinal axis, the prong opening extending through the plate body; and

a rod opening extending along the axis oblique to the longitudinal axis through the plate body on the opposing side of the longitudinal axis;

a holder comprising:

a holder body having a proximal end, a distal end adapted to engage the plate, a mid portion disposed between the proximal end and the distal end, and a channel extending between the proximal end and the distal end; and

a prong extending distally from the distal end, the prong sized to extend through the prong opening and into the prong receiver; and

a rod having a distal end, the rod being sized to be inserted into the proximal end of the holder body, through the channel in the holder body, through the rod opening in the plate and into the spacer such that the distal end of the rod releasably engages the rod receiver.

2. The spacer assembly according toclaim 1, wherein the channel has an arcuate portion.

3. The spacer assembly according toclaim 1, wherein the proximal end of the holder body has a first width and the mid portion of the holder body has a second width, less than the first width.

4. The spacer assembly according toclaim 1, wherein the rod is constructed from an elastic metal.

5. The spacer assembly according toclaim 1, wherein the holder is constructed from an upper portion and a lower portion, the lower portion being bonded to the upper portion.

6. The spacer assembly according toclaim 1, wherein the prong receiver is open to the inner space.

7. The spacer assembly according toclaim 1, wherein the mid portion extends wholly on one side of the longitudinal axis.

8. The spacer assembly according toclaim 1, wherein the rod distal end comprises a male thread sized to threadingly engage the blind threaded hole.

9. The spacer assembly according toclaim 1, wherein when the prong is inserted into the prong receiver and when the rod distal end is inserted into the rod receiver, the spacer is releasably connected to the holder.

10. The spacer assembly according toclaim 1, wherein the spacer comprises a “C” shaped body.

11. The spacer assembly according toclaim 1, wherein the first lateral side comprises a first indentation and wherein the second lateral side comprises a second indentation, wherein the first finger is releasably insertable into the first indentation and the second finger is releasably insertable into the second indentation.

12. The spacer assembly according toclaim 1, wherein the rod opening is unthreaded.

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